An observational study in ARDS (Acute Respiratory Distress Syndrome), sponsored by Hiroshima University. Enrolling by invitation at 1 site in Japan. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Hiroshima University · Observational
EXTEND ARDS study is an international survey for ventilator weaning and extubation among ARDS patients. This study will be conducted on behalf of the Japanese ARDS Clinical Practice Guideline 2024 Committee as well as endorsement of the Japanese Society of Intensive Care Medicine, the Japanese Respiratory Society, and the Japanese Society of Respiratory Care Medicine. This survey aims to prospectively collect the clinical data of mechanically ventilated ARDS patients related with ventilator weaning and extubation internationally as well as the outcome of ARDS patients with extubation failure. This study also aims to identify predictive factors strongly associated with extubation failure. The contents of mechanical ventilation settings, respiratory conditions, and blood examination data will be collected.
1.1. Background
Acute respiratory distress syndrome (ARDS) is a life-threatening condition characterized by widespread inflammatory lung injury, and is encountered in an estimated 23% of mechanically ventilated patients (1). Recent studies reported that the mortality of mechanically ventilated patients with ARDS was still as high as approximately 40% (1), which implies that better management strategies for them are needed to improve the outcomes.
In the management for the mechanical ventilated patients with ARDS, the timing and judgement for extubation is clinically important, because extubation failure can be associated with worse outcome (2). The most recent ARDS guidelines recommend a weaning protocol for extubation and introduced several predictive clinical factors for extubation failure, but they are mainly based on the studies for patients with acute respiratory failure (3), and there is no study focusing on the patients with ARDS. Considering that the best method to extubate successfully has not been determined, the clinical management at the timing of extubation can be varied by each institution or each country, and the investigators thought that international survey focusing on the management for extubation of ARDS patients would be needed.
1.2. Significance of the study
Our international survey can identify the management associated with better outcome as well as clinical factors to predict extubation failure at the timing of extubation attempt. This study will contribute to the development of better management for extubation and thereby improve the outcomes of patients with ARDS.
This study has the potential to increase the generalizability of the results which will be obtained from all regions of the world, including Asia, Europe, North and South America, Oceania, and Africa. Therefore, the results will potentially contribute to improving patient outcomes in all regions of the world. Furthermore, the results obtained will provide a detailed picture of the current ICU management given to mechanical ventilated patients with ARDS in the ICU.
1.3．Study Design
This study is international multicenter prospective survey.
2.2. Aim of the study Aim 1: Describing epidemiology, management, timing, and outcome for ventilator weaning and extubation of ARDS patients in the world Aim 2: Comparing the protocol for weaning and extubation between the ARDS patients who had successful extubation and those who did not Aim 3: Comparing the change of respiratory mechanics in the SBT and post-extubation between the ARDS patients who had successful extubation and those who did not Aim 4: Identifying clinical factor available during SBT and in the early times after extubation for predicting extubation failure
382 studies on the registry are indexed under Acute Lung Injury; 73 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 100 across 131 observational studies indexed under Acute Lung Injury.
Browse Acute Lung Injury studies →Hiroshima University is the lead sponsor of 45 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult mechanically ventilated patients (≥ 16 years old) expected to receive invasive mechanical ventilator for more than 48 hours
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Exclusion Criteria:
Adult mechanically ventilated patients (≥ 16 years old) expected to receive invasive mechanical ventilator for more than 48 hours
90 days in-hospital mortality
90 days in-hospital mortality
Time frame: From intubation to 90 days after intubation
occurrence of re-intubation event
occurrence of re-intubation event
Time frame: From extubation until the hospital discharge, assessed up to 24 months
Plan to share: Yes — Study protocol
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Started Nov 2024 (actual). Primary completion is estimated for Oct 2025, 11 months after the start.
Of 41 non-industry observational studies under Acute Lung Injury, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's planned 11 months is below that.
Counting every sponsor, half of 46 studies reached it within 18 months; a quarter within 8 and three quarters within 47.
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Hiroshima University